Robert Jarrin, senior director of government affairs at Qualcomm Incorporated – like most people involved in the mHealth world – is waiting with bated breath for the Food and Drug Administration to finalize its mobile medical apps guidance.
The draft guidance was issued in July 2011, and recently FDA officials alluded to a final release before this October.
“FDA should promptly finalize the MMA draft guidance document,” Jarrin urged recently at a congressional hearing. But that’s not his only request for the FDA. The final MMA guidance should offer specific examples of low-risk, regulated mobile medical devices that FDA, through enforcement discretion, would not regulate.
Jarrin agrees that low-risk apps are a murky area. “The take-away is, we need more clarity,” he told Healthcare IT News. “My feeling is as you get into higher risk devices, it’s much less murky.”
[See also: Where is the fine line between safety and free rein for mobile development?]
Jarrin has been working for Qualcomm for 13 years and began his role in government affairs for the company in 2001. The bulk of his work involves working with federal agencies, he says.
“For a guy like me, as involved as I am, the murkiness comes from whether or not the FDA should regulate those devices that are so low risk [that they don’t pose a threat to the public]; should the agency expend the time and energy to do so?”
In the draft guidance, the FDA has given a few examples of low risk devices, including educational tools, low risk medication reminders, IV drug dose calculators, BMI calculators and substance abuse behavior guides. Jarrin would like to see more.
[See also: mHealth app market poised for big growth.]
Jarrin, on behalf of Qualcomm, would also like the FDA to:
- Provide more clarity on the terms “intended use,” in light of ambiguous and general health claims and terms that are popularly used by the health IT industries.
- For those apps that warrant listing as low-risk Class I devices, the agency should consider how it will assess exemption from good manufacturing practices (GMP), a costly and time-consuming regulatory process that Jarrin feels isn’t needed for low-risk devices.
- Accessories should be classified according to their individual level of risk and not according to the device with the highest classification level. “This is a big deal in the medical space,” Jarrin says. “It’s very problematic in a software world.” Modular components added to a device—even something as simple as changing a display—must take on that device’s classification level. “It opens up a very thorny area of the law that FDA has done little to answer. We’re trying to push this topic,” he says.
- FDA should continue its commitment to consistency, predictability and transparency by coordinating internal and external efforts through a single dedicated office of mobile health within FDA. “So much is being done in the mobile health world,” Jarrin says. “Somebody should control this at the FDA. It would be great if FDA had an office of health IT or mobile health within the agency.”
- FDA should push their useful resources more; make the public more aware of “CDRH Learn,” “Device Advice” and the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) to work with app developers and their communities. “The FDA has incredible learning resources on their website,” Jarrin says. “They’re all really great and [the FDA] should extol those and tweak them.”
